- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Pwynt Penodol mewn Amser (31/01/2020)
- Gwreiddiol (Fel y’i mabwysiadwyd gan yr UE)
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance)
Pan adawodd y DU yr UE, cyhoeddodd legislation.gov.uk ddeddfwriaeth yr UE a gyhoeddwyd gan yr UE hyd at ddiwrnod cwblhau’r cyfnod gweithredu (31 Rhagfyr 2020 11.00 p.m.). Ar legislation.gov.uk, mae'r eitemau hyn o ddeddfwriaeth yn cael eu diweddaru'n gyson ag unrhyw ddiwygiadau a wnaed gan y DU ers hynny.
Mae legislation.gov.uk yn cyhoeddi fersiwn y DU. Mae EUR-Lex yn cyhoeddi fersiwn yr UE. Mae Archif Gwe Ymadael â’r UE yn rhoi cipolwg ar fersiwn EUR-Lex o ddiwrnod cwblhau’r cyfnod gweithredu (31 Rhagfyr 2020 11.00 p.m.).
Point in time view as at 31/01/2020.
There are currently no known outstanding effects by UK legislation for Regulation (EU) 2017/746 of the European Parliament and of the Council, Division 3.2..
Revised legislation carried on this site may not be fully up to date. At the current time any known changes or effects made by subsequent legislation have been applied to the text of the legislation you are viewing by the editorial team. Please see ‘Frequently Asked Questions’ for details regarding the timescales for which new effects are identified and recorded on this site.
Specific qualification criteria shall be defined at least for the assessment of:
biological safety,
performance evaluation,
devices for self and near patient testing,
companion diagnostics,
functional safety,
software,
packaging, and
the different types of sterilisation processes.
Union devices legislation and relevant guidance documents;
the conformity assessment procedures provided for in this Regulation;
a broad base of knowledge of device technologies and the design and manufacture of devices;
the notified body's quality management system, related procedures and the required qualification criteria;
training relevant to personnel involved in conformity assessment activities in relation to devices;
adequate experience in conformity assessments under this Regulation or previously applicable law within a notified body.
identify when specialist input is required for the assessment of the performance evaluation conducted by the manufacturer and identify appropriately qualified experts;
appropriately train external clinical experts in the relevant requirements of this Regulation, CS, guidance and harmonised standards and ensure that the external clinical experts are fully aware of the context and implications of their assessment and the advice they provide;
be able to review and scientifically challenge the clinical data contained within the performance evaluation, and any associated performance study, and appropriately guide external clinical experts in the assessment of the performance evaluation presented by the manufacturer;
be able to scientifically evaluate and, if necessary, challenge the performance evaluation presented, and the results of the external clinical experts' assessment of the manufacturer's performance evaluation;
be able to ascertain the comparability and consistency of the assessments of performance evaluation conducted by clinical experts;
be able to make an assessment of the manufacturer's performance evaluation and a clinical judgement of the opinion provided by any external expert and make a recommendation to the notified body's decision maker; and
be able to draw up records and reports demonstrating that the relevant conformity assessment activities have been appropriately carried out.
successful completion of a university or a technical college degree or an equivalent qualification in relevant studies, such as medicine, pharmacy, engineering or other relevant sciences;
four years' professional experience in the field of healthcare products or related activities, such as in manufacturing, auditing, or research, of which two years shall be in the design, manufacture, testing or use of devices or technology to be assessed or related to the scientific aspects to be assessed;
knowledge of device legislation, including the general safety and performance requirements set out in Annex I;
appropriate knowledge and experience of relevant harmonised standards, CS and guidance documents;
appropriate knowledge and experience of risk management and related device standards and guidance documents;
appropriate knowledge and experience of performance evaluation;
appropriate knowledge of the devices which they are assessing;
appropriate knowledge and experience of the conformity assessment procedures laid down in Annexes IX to XI, in particular of the aspects of those procedures for which they are responsible, and adequate authorisation for carrying out those assessments;
the ability to draw up records and reports demonstrating that the relevant conformity assessment activities have been appropriately carried out.
successful completion of a university or a technical college degree or equivalent qualification in relevant studies, such as medicine, pharmacy, engineering or other relevant sciences;
four years' professional experience in the field of healthcare products or related activities, such as in manufacturing, auditing or research, of which two years shall be in the area of quality management;
appropriate knowledge of devices legislation as well as related harmonised standards, CS and guidance documents;
appropriate knowledge and experience of risk management and related device standards and guidance documents;
appropriate knowledge of quality management systems and related l devices standards and guidance documents;
appropriate knowledge and experience of the conformity assessment procedures laid down in Annexes IX to XI, in particular of the aspects of those procedures for which they are responsible, and adequate authorisation for carrying out those audits;
training in auditing techniques enabling them to challenge quality management systems;
the ability to draw up records and reports demonstrating that the relevant conformity assessment activities have been appropriately carried out.
devices legislation and relevant guidance documents;
device conformity assessments relevant to this Regulation;
the types of qualifications, experience and expertise relevant to device conformity assessment;
a broad base of knowledge of device technologies, including sufficient experience of the conformity assessment of devices being reviewed for certification, the device industry and the design and manufacture of devices;
the notified body's quality system, related procedures and the required qualifications for personnel involved;
the ability to draw up records and reports demonstrating that the conformity assessment activities have been appropriately carried out.
The Whole Regulation you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
Y Rhestrau you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
Y Diweddaraf sydd Ar Gael (diwygiedig):Y fersiwn ddiweddaraf sydd ar gael o’r ddeddfwriaeth yn cynnwys newidiadau a wnaed gan ddeddfwriaeth ddilynol ac wedi eu gweithredu gan ein tîm golygyddol. Gellir gweld y newidiadau nad ydym wedi eu gweithredu i’r testun eto yn yr ardal ‘Newidiadau i Ddeddfwriaeth’.
Gwreiddiol (Fel y’i mabwysiadwyd gan yr UE): Mae'r wreiddiol version of the legislation as it stood when it was first adopted in the EU. No changes have been applied to the text.
Pwynt Penodol mewn Amser: This becomes available after navigating to view revised legislation as it stood at a certain point in time via Advanced Features > Show Timeline of Changes or via a point in time advanced search.
Rhychwant ddaearyddol: Indicates the geographical area that this provision applies to. For further information see ‘Frequently Asked Questions’.
Dangos Llinell Amser Newidiadau: See how this legislation has or could change over time. Turning this feature on will show extra navigation options to go to these specific points in time. Return to the latest available version by using the controls above in the What Version box.
Gallwch wneud defnydd o ddogfennau atodol hanfodol a gwybodaeth ar gyfer yr eitem ddeddfwriaeth o’r tab hwn. Yn ddibynnol ar yr eitem ddeddfwriaeth sydd i’w gweld, gallai hyn gynnwys:
Mae’r llinell amser yma yn dangos y fersiynau gwahanol a gymerwyd o EUR-Lex yn ogystal ag unrhyw fersiynau dilynol a grëwyd ar ôl y diwrnod ymadael o ganlyniad i newidiadau a wnaed gan ddeddfwriaeth y Deyrnas Unedig.
Cymerir dyddiadau fersiynau’r UE o ddyddiadau’r dogfennau ar EUR-Lex ac efallai na fyddant yn cyfateb â’r adeg pan ddaeth y newidiadau i rym ar gyfer y ddogfen.
Ar gyfer unrhyw fersiynau a grëwyd ar ôl y diwrnod ymadael o ganlyniad i newidiadau a wnaed gan ddeddfwriaeth y Deyrnas Unedig, bydd y dyddiad yn cyd-fynd â’r dyddiad cynharaf y daeth y newid (e.e. ychwanegiad, diddymiad neu gyfnewidiad) a weithredwyd i rym. Am ragor o wybodaeth gweler ein canllaw i ddeddfwriaeth ddiwygiedig ar Ddeall Deddfwriaeth.
Defnyddiwch y ddewislen hon i agor dogfennau hanfodol sy’n cyd-fynd â’r ddeddfwriaeth a gwybodaeth am yr eitem hon o ddeddfwriaeth. Gan ddibynnu ar yr eitem o ddeddfwriaeth sy’n cael ei gweld gall hyn gynnwys:
liciwch ‘Gweld Mwy’ neu ddewis ‘Rhagor o Adnoddau’ am wybodaeth ychwanegol gan gynnwys